Bioavailability Study of a New Pediatric Formulation of Zidovudine/Lamivudine in Adult Volunteers
NCT ID: NCT00470041
Last Updated: 2010-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2007-06-30
2009-12-31
Brief Summary
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Interventions: 12 healthy volunteers will receive in a cross-over design two formulations i.e. the commercially available tablet formulation and the trial formulation. Blood samples (13 over 24 h) will be taken in order to determine the pharmacokinetic profile of the drugs from both formulations and will be compared.
Duration of intervention: 2 days + 7 days of wash-out between both oral administrations.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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administration of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation
Eligibility Criteria
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Inclusion Criteria
* Smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day (or non-smoking) for at least 3 months prior to selection.
* Normal weight as defined by a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
* Subject is competent and willing to sign informed consent form after being given all the detailed information about the study. Informed consent form signed voluntarily.
* Healthy on the basis of a pre-trial physical examination, medical history, electrocardiogram and the results of blood biochemistry and haematology tests and a urinalysis carried out less than 3 weeks before the first dose.
Exclusion Criteria
* Subjects with kidney failure or renal dysfunction
* Pregnant, lactating females
* History of allergy or hypersensitivity to Zidovudine or Lamivudine.
* History of clinically cardiovascular disease or liver disorder
18 Years
55 Years
ALL
Yes
Sponsors
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University Ghent
OTHER
Responsible Party
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University Ghent
Principal Investigators
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Luc Van Bortel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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University Hospital Ghent
Ghent, , Belgium
Countries
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Related Links
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Website University Hospital Ghent
Other Identifiers
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2007/155
Identifier Type: -
Identifier Source: org_study_id
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